Ocular device for treating glaucoma and related minimally invasive glaucoma surgery method

Abstract

A bypass device is implanted into a body tissue via a minimally invasive surgery to provide fluid channels through the body tissue. The bypass device includes a base portion having opposite first and second ends, and flexed tines attached to the base portion configured in a flexed position relative to the base portion. The base portion includes flow spaces present from where the flexed tines are flexed relative to the base portion, the flow spaces permitting fluid flow through the bypass device. The bypass device further includes an anchor tine located adjacent to the second end of the base portion that aids in securing the bypass device in place after implantation. The bypass device may be implanted in the eye using a MIGS procedure for the treatment of glaucoma, whereby aqueous humor is permitted to flow through the flow spaces of the bypass device.

1 . A bypass device for providing fluid channels through a body tissue, the bypass device comprising:
 a base portion having a first end and a second end opposite from the first end;   a first flexed tine and a second flexed tine attached to the base portion and configured in a flexed position relative to the base portion, the first flexed tine being positioned closest to the first end of the base portion and the second flexed tine being positioned between the first flexed tine and the second end of the base portion;   the base portion including a first flow space present from where the first flexed tine is flexed relative to the base portion and a second flow space present from where the second flexed tine is flexed relative to the base portion, the first and second flow spaces permitting fluid flow through the bypass device; and   an anchor tine located adjacent to the second end of the base portion, and the second flexed tine is positioned between the first flexed tine and the anchor tine.   
     
     
         2 . The bypass device of  claim 1 , wherein the first flexed tine and the second flexed tine each extends from the base portion at an acute angle relative to the base portion, and the anchor tine extends at an obtuse angle relative to the base portion. 
     
     
         3 . The bypass device of  claim 1 , wherein each of the first flexed tine, the second flexed tine, and the anchor tine includes a respective attachment portion at which a respective tine is attached to the base portion. 
     
     
         4 . The bypass device of  claim 3 , wherein each of the first flexed tine, the second flexed tine, and the anchor tine includes a respective curved portion that extends from the respective attachment portion, and a respective body that extends from the respective curved portion. 
     
     
         5 . The bypass device of  claim 4 , wherein the curved portion of the first flexed tine and the curved portion of the second flexed tine each extends from the base portion at an acute angle relative to the base portion, and the curved portion of the anchor tine extends at an obtuse angle relative to the base portion. 
     
     
         6 . The bypass device of  claim 5 , wherein the obtuse angle of the curved portion of the anchor tine acts to generate a holding force to aid in maintaining the bypass device in place after implantation. 
     
     
         7 . The bypass device of  claim 5 , wherein the obtuse angle of the curved portion of the anchor tine is from 150° to 170°. 
     
     
         8 . The bypass device of  claim 1 , wherein the flexed position of each of the first flexed tine and the second flexed tine creates a flat spring with an associated spring force. 
     
     
         9 . The bypass device of  claim 1 , wherein each of the first flexed tine, the second flexed tine, and the anchor tine includes a respective arrow end. 
     
     
         10 . The bypass device of  claim 1 , wherein the base portion has a curvature that approximates a curvature of iridocorneal angle structures. 
     
     
         11 . A method of performing a minimally invasive glaucoma surgery (MIGS) for treating glaucoma comprising the steps of:
 providing a bypass device for bypassing a drainage system of an eye including a Schlemm's canal, trabecular meshwork, and collector channels, the bypass device comprising:
 a base portion having a first end and a second end opposite from the first end; 
 a first flexed tine and a second flexed tine attached to the base portion configured in a flexed position relative to the base portion, the first flexed tine being positioned closest to the first end of the base portion and the second flexed tine being positioned between the first flexed tine and the second end of the base portion; 
 the base portion including a first flow space present from where the first flexed tine is flexed relative to the base portion and a second flow space present from where the second flexed tine is flexed relative to the base portion, the first and second flow spaces permitting fluid flow through the bypass device; and 
 an anchor tine located adjacent to the second end of the base portion, and the second flexed tine is positioned between the first flexed tine and the anchor tine; 
   providing an introducer comprising a cannula and an advancing plunger that is threaded into the cannula;   locating the bypass device within the cannula at an initial retracted position with the advancing plunger being positioned in the cannula rearward relative to the bypass device;   forming a guide hole to access the Schlemm's canal at the trabecular meshwork of the eye;   inserting the cannula with the bypass device and advancing plunger through the guide hole and positioning the cannula adjacent to the trabecular meshwork;   operating the introducer to operate the advancing plunger to advance the bypass device through the cannula from the initial retracted position to an intermediate position to expose the first and second flexed tines from the cannula;   puncturing the trabecular meshwork with ends of the first and second flexed tines and forcing the flexed tines through the trabecular meshwork;   operating the introducer to operate the advancing plunger to further advance the bypass device through the cannula from the intermediate position to an extended position;   wherein as the bypass device advances from the initial retracted position to the extended position, the flexed tines tear an elongated flow hole through trabecular meshwork, such that when the bypass device reaches the extended position the elongated flow hole is aligned with the flow spaces of the base portion of the bypass device, and aqueous humor is permitted to flow through the flow spaces of the bypass device, and then through the aligned elongated flow hole through the trabecular meshwork and into the Schlemm's canal so that the aqueous humor can drain; and   retrieving the cannula with the advancing plunger while leaving the bypass device in place, wherein when the bypass device has reached the extended position and the cannula is removed, the anchor tine is positioned against an inner surface of the trabecular meshwork, and a curvature of the anchoring tine as positioned against the inner surface of the trabecular meshwork acts to generate a holding force to aid in maintaining the bypass device in place.   
     
     
         12 . The MIGS method of  claim 11 , wherein the bypass device is configured according to any of  claims 2-10 . 
     
     
         13 . The MIGS method of  claim 11 , wherein the introducer further includes a first slider and a second slider, the method further comprising operating the first slider to operate the advancing plunger to advance the bypass device from the initial retracted position to the intermediate position and operating the second slider to operate the advancing plunger advance the bypass device from the intermediate position to the extended position. 
     
     
         14 . The MIGS method of  claim 11 , wherein the flexed position of each of the first flexed tine and the second flexed tine creates a flat spring with an associated spring force, and puncturing the trabecular meshwork comprises applying pressure with the ends of the first and second flexed tines against the trabecular meshwork to compress the first and second flexed tines against the spring force, such that the spring force aids the to push the ends of the first and second flexed tines through the trabecular meshwork. 
     
     
         15 . The MIGS method of  claim 11 , wherein when the bypass device is in the extended position, the anchor tine has a curvature that extends along an inner surface of the trabecular meshwork in opposition to the curvature of the inner surface, such that a force interaction between the anchor tine and the inner surface of the trabecular meshwork tends to rotate the base portion of the bypass device to press the base portion against the inner surface of the trabecular meshwork to aid in maintaining the bypass device in place. 
     
     
         16 . The MIGS method of  claim 11 , wherein the introducer further includes a curved stent attached to a forward end of the cannula, and the bypass device passes through the curved stent when the introducer is operated. 
     
     
         17 . The MIGS method of any of  claim 11 , further comprising performing a visualization technique to locate clogged portions of the drainage system, wherein the bypass device is aligned relative to the trabecular meshwork such that the first and second flexed tines are positioned at or adjacent to respective clogged portions of the trabecular meshwork as determined by the visualization technique. 
     
     
         18 . The MIGS method of  claim 11 , further comprising injecting a viscoelastic substance through the cannula and into the Schlemm's canal to expand the Schlemm's canal to aid positioning the bypass device. 
     
     
         19 . The MIGS method of  claim 11 , further comprising introducing one or more substances into the Schlemm's canal through the cannula, wherein the one or more substances include one or more of a glaucoma medication, an anti-inflammatory agent, and an antibiotic releasing pellet. 
     
     
         20 . The MIGS method of  claim 11 , wherein the advancing plunger includes a holding device, the MIGS method further comprising holding the bypass device at the anchor tine with the holding device while advancing the bypass device with the advancing plunger.